MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-09-28 for CARBON SURGICAL BLADES 15 4-115 manufactured by Miltex, Inc..
[1325367]
The rn supervisor reported via telephone. The doctor recorded in the patient's chart that the tip of the #15 blade broke where it attached to the scalpel handle during an open rhinoplasty with septoplasty, bilateral inferior turbinate infracture and mucosal coagulation. He was unable to locate/remove the one broken piece. An x-ray showed the piece of blade in the patient's stomach. It was removed via endoscopy without incident. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8405066]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221336-2009-00004 |
| MDR Report Key | 1509922 |
| Report Source | 06 |
| Date Received | 2009-09-28 |
| Date of Report | 2009-09-28 |
| Date of Event | 2009-06-11 |
| Date Facility Aware | 2009-09-22 |
| Date Mfgr Received | 2009-09-22 |
| Date Added to Maude | 2010-08-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBON SURGICAL BLADES 15 |
| Generic Name | M5 - GENERAL SURGERY |
| Product Code | KTG |
| Date Received | 2009-09-28 |
| Catalog Number | 4-115 |
| Lot Number | C08F02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTEX, INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-28 |